The drugs don't work by canttakesky

REAL WORLD EVENT DISCUSSIONS

The drugs don't work

POSTED BY: CANTTAKESKY
UPDATED: Thursday, September 27, 2012 07:21
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Saturday, September 22, 2012 3:41 AM

Finally, a physician discovers what the rest of us already know. Medicine is not a science. Medical journals are simply ads for Big Pharma. And it's called publication bias--which they apparently don't teach in medical school.

Quote:

http://www.guardian.co.uk/business/2012/sep/21/drugs-industry-scandal-
ben-goldacre?fb=optOut

The drugs don't work: a modern medical scandal

The doctors prescribing the drugs don't know they don't do what they're meant to. Nor do their patients. The manufacturers know full well, but they're not telling.

Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I'd read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It's approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients' worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn't bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

... Read more at the link.

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Saturday, September 22, 2012 4:03 AM

KWICKO

"We'll know our disinformation program is complete when everything the American public believes is false." -- William Casey, Reagan's presidential campaign manager & CIA Director (from first staff meeting in 1981)

I kind of thought this was widely known already.

Drug companies pay for lots and lots of "studies"... and then publish only the results that make their new wonder drug look like it works.

"I supported Bush in 2000 and 2004 and intellegence [sic] had very little to do with that decision." - Hero

Mitt Romney, introducing his running mate: "Join me in welcoming the next President of the United States, Paul Ryan!"

Rappy's response? "You're lying, gullible ( believing in some BS you heard on msnbc ) or hard of hearing."

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Saturday, September 22, 2012 4:34 AM

SIGNYM

I believe in solving problems, not sharing them.

Quote:
I kind of thought this was widely known already.

Yeah, I thought so too. I recall a news item about 8 years ago on exactly the same theme: the manufacturer of Synthroid (the brand-name version of the thyroid hormone replacement levothyroxin) paid a university medical doctor/ researcher to run tests to determine if generic and brand-name were equally effective. Nine studies later, only one was published - the one which showed that Synthroid was more effective. The twist on the tale was that the researcher was so upset that the other studies had been withheld that SHE published them... and was sued because the pharma said that they paid for the studies and therefore the results were theirs not hers. (I never did hear the end of that court case. But having worked for a private consulting lab many years ago, I can tell you that's how things work.) The President of Glaxo Smith Klein came out four years ago and said himself that any particular drug will only work with about 30% of the people who take it.

Many drugs DO work. Anesthetics reliably put people to sleep for surgery. Antibiotics reliably kill non-resistant pathogens. Steroids reliably reduce swelling. Even artorvastatin reliably reduces cardiac events, on a population basis.

But not all drugs work for all people, and some drugs work in so few cases they're almost not worth prescribing... except for the few cases where they DO work. And drugs are quite often over-prescribed.

But to say that ALL drugs do nothing is, of course, an exaggeration and simply not true.

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Saturday, September 22, 2012 5:39 AM

BYTEMITE

This is why I think whenever anyone prescribes a drug, they should know the complete pathway of the drug. Where it goes, what it acts on, why, the chemistry, why there might be side effects, and where it goes after it's done.

With many drugs, it's often a reasonable guess that, oh, the drug has this group, which is like the group on this other compound, so it's likely to do this. And that's not necessarily bad, though sometimes those less known drugs don't act as expected in vivo.

But other times, something is synthesized that the drug company has not even a guess what's the active group and what it might do, so they perform studies, like these, to see if they can get some data that supports it's effectiveness on some condition or another. These trials will be varied across the spectrum of human illness, mental health to heart problems to liver and so on, until they find something that they can publish works for one particular thing, but then their results for that one particular thing can be a false positive.

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Saturday, September 22, 2012 5:45 AM

NIKI2

Gettin' old, but still a hippie at heart...

Nasty subject, especially as I take more than a few pills every day, and one of them IS Synthroid! My thyroid always tests fine, and it didn't before, so I guess I'll just go on taking it, but I certainly know what you and Byte are saying and fully agree. And yeah, I've heard enough of study suppression over time that it's not surprising to me. Actually not much Big Pharma can DO would surprise me, they get away with an awful lot.

As to over-prescribing, HAH, that's the understatement of the week, ain't it?!

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Saturday, September 22, 2012 5:52 AM

DREAMTROVE

Quote:
Byte:

This is why I think whenever anyone prescribes a drug, they should know the complete pathway of the drug. Where it goes, what it acts on, why, the chemistry, why there might be side effects, and where it goes after it's done.

This is so well said I can't think of anything to add.

ETA: Maybe that patent law causes the new drugs to be prescribed and old ones to be abandoned. You will always get some cases where a drug "worked" because some elements are random and somewhere around a third of patients will take some form of alternative treatment along side anything they get from the doctors, and doctors are prone to ascribe any positive changes to the drug they prescribed.

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Saturday, September 22, 2012 8:18 AM

FREMDFIRMA

Actually, I have a proposal here that might satisfy all of us, odd that it sounds since we're usually all but cannon shelling each other in regards to this...

Now, it grinds me a bit to suggest actually expanding or increasing funding for a *gaghackspit* Government agency, but the truth is there's no way in bloody hell joe sixpack can test all this crap for themselves, it just ain't possible.

Substantially expand the FDA, increase it's funding significantly, while barring personnel exchange with Big Pharma via both conflict-of-interest and compliance/NDA type measures, and I mean that in BOTH directions - if you work for the FDA you can't jump ship to Big Pharma, as well as vice versa.
Additionally, I would support subsidizing the education of folks interested in a scientific career in exchange for a contractual agreement to work for the FDA, along with internship and apprenticeship programs.
(PAID ones, REAL ones, not bullshit abusive ones like Corpos use, or crummy useless makework either - there *IS* plenty of "grunt work" to be done in science which requires less skill and training, and this will ease them in and take the load off the high end people)

In exchange for this I would ask the removal of the FDA's enforcement power in regard to anything but truth in labelling, as well as a degree of seperation from other Government agencies in order to provide a bulwark against corruption of the process - allow them to sell their drugs, supplements, what have you, so long as the potential customer is PROPERLY INFORMED OF WHAT THE EFFECTS ARE, both in practice and potential.
If the customer chooses something that may or may not "officially" work, or something that may be harmful to them, let that be the customers decision and remove the moral judgement element - they were informed, they made a choice.

That's just an unrefined, first-thought suggestion, but I think it has legs.
Think we can work with this ?

-Frem

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Saturday, September 22, 2012 9:02 AM

CANTTAKESKY

Quote:
Originally posted by DREAMTROVE:
Quote:
Byte:
This is why I think whenever anyone prescribes a drug, they should know the complete pathway of the drug. Where it goes, what it acts on, why, the chemistry, why there might be side effects, and where it goes after it's done.

This is so well said I can't think of anything to add.

Well I can add this. They should know, but more often than not, they don't. Mechanistics studies, indeed science itself, are slow. They know part of the pathway, some of the chemistry, some acute side effects but not the long term ones... Drugs are always a work in progress.

So do we not allow them until the complete pathway is known? Or do we allow them to market the drugs with what little they do know, as long as there is truth in labeling?

I'm with Frem re truth in labeling. I would like to see the FDA change its mandate to enforcing labeling ONLY. With ties cut completely with Big Pharma. My only disagreement there is I don't see why reducing FDA responsibilities should result in expanding its budget.

So I say let everyone market whatever drug they have, even if the knowledge on the mechanism is in its infancy. Just make sure people know how little we really know about each drug. Truth in labeling.

Something Big Pharma won't have.

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Saturday, September 22, 2012 9:08 AM

BYTEMITE

>_> Actually I think the average joe six pack CAN understand this stuff. People in general have about the same amount of brain utilization they can manage without burning themselves out regardless of ethnicity or gender or social strata. Plus, this stuff really isn't that hard provided people haven't been conditioned to cross their eyes and turn their brains off whenever numbers come up in text.

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Saturday, September 22, 2012 9:06 PM

FREMDFIRMA

Quote:
Originally posted by canttakesky:
So do we not allow them until the complete pathway is known? Or do we allow them to market the drugs with what little they do know, as long as there is truth in labeling?

I'm with Frem re truth in labeling. I would like to see the FDA change its mandate to enforcing labeling ONLY. With ties cut completely with Big Pharma. My only disagreement there is I don't see why reducing FDA responsibilities should result in expanding its budget.

Well, how bout this...

Quote:
EXPERIMENTAL:
This drug has not been sufficiently tested for safety and effectiveness, any use should be considered "off-label" and physicians should refrain from prescribing save at patient request.

And then add what they do know, yes ?
Works for me.

As for budget/personnel expansion, simple logistics - the FDA flat out does not have, at this time, the resources or personnel to do it's job effectively... I mean it, they really don't.
Automation and refining the process can only do so much, the greatest need is for boots on the ground - right now a lot slips by cause there just ain't ENOUGH inspectors/testors/what-have-you, and I am bloody well aware of it.
So sometimes ya gotta make the tradeoff, and I would rather do it up front, from both a financial and safety perspective, than playing catch up trying to get stuff off the shelves after it's killed some folk, yadda yadda.

Cheap at the price, AND one could also sell it on the employment aspect too, more jobs, more people working instead of starving, even if science types are often underpaid, alas.

-Frem

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Sunday, September 23, 2012 1:44 AM

CANTTAKESKY

Quote:
Originally posted by FREMDFIRMA:
Quote:
EXPERIMENTAL:
This drug has not been sufficiently tested for safety and effectiveness, any use should be considered "off-label" and physicians should refrain from prescribing save at patient request.

Yep, I can live with that.

Quote:
As for budget/personnel expansion, simple logistics - the FDA flat out does not have, at this time, the resources or personnel to do it's job effectively... I mean it, they really don't.
OK. If we're going to have an FDA, or any federal agency, we should fund it correctly and not half-assed. I'm ok with that.

I would prefer to have truth in labeling monitored by an NGO. But life is full of compromises.

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Sunday, September 23, 2012 12:16 PM

MAGONSDAUGHTER

I sometimes feel like the doctors in the US have no ethics whatsoever. If a drug is still at clinical trial stage, not only should they let you know ethically, you should not be required to pay for it.

The drugs can and do work, but there needs to be some cleaning up of practises around prescribing and how these drugs are clincally trialled.

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Sunday, September 23, 2012 3:27 PM

CANTTAKESKY

Quote:
Originally posted by Magonsdaughter:
I sometimes feel like the doctors in the US have no ethics whatsoever. If a drug is still at clinical trial stage, not only should they let you know ethically, you should not be required to pay for it.

The article was written by a physician in the UK. And Reboxetine was not in clinical trials. They were already approved by the UK version of the FDA.

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Sunday, September 23, 2012 5:34 PM

CHRISISALL

Quote:
Originally posted by Magonsdaughter:
I sometimes feel like the doctors in the US have no ethics whatsoever.

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Sunday, September 23, 2012 6:14 PM

1KIKI

Goodbye, kind world (George Monbiot) - In common with all those generations which have contemplated catastrophe, we appear to be incapable of understanding what confronts us.

I would really like to see a thoughtful discussion of this ...

I recommend these articles, which are what scientists say to each other, about each others' work, about the process of drug testing, about what is the nature of the science, and about what they think it means:

http://the-scientist.com/2012/05/01/data-diving/
Data Diving
What lies untapped beneath the surface of published clinical trial analyses could rock the world of independent review.
"There’s been an understanding for some time that publication bias is a real occurrence, and that it often favors the drug. Trials that show no efficacy are less likely to get into print than trials that demonstrate a positive effect. So when Lisa Bero at the University of California, San Francisco, decided to redo 42 published meta-analyses of drugs and include unpublished, but available, data, she suspected the drugs would fare poorly. “But that’s not what we found,” she says."

http://the-scientist.com/2012/05/14/opinion-misleading-drug-trials/
Opinion: Misleading Drug Trials
Amgen’s incomplete report on an early major trial of epoetin misled the medical community about the anemia drug’s risks and benefits—and helped make Amgen rich.
"The academic authors of the 1998 publication state there was no intent to mislead, claiming the NEJM editors removed from drafts all the adverse results that I reported in 2012. They also state the 1998 publication clearly discouraged targeting hematocrit to 42 percent. What the 1998 publication did not do, however, was make clear, as my report does, that higher epoetin doses carry great risks, while the only benefit was a meager reduction in transfusion risk at great monetary cost."

http://the-scientist.com/2012/05/23/overhauling-industry-sponsored-stu
dies/
Overhauling Industry-Sponsored Studies
Major pharmaceutical companies have agreed to a handful of recommendations aimed at increasing the transparency of clinical trials they fund.
"All clinical trial findings—even negative ones—will be made public, author contributions to manuscripts will be made clear, and study authors will have full access to all trial data in industry-funded clinical trials if a list of recommendations hashed out by editors at top medical journals and eight major pharmaceutical companies are actually implemented."

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Sunday, September 23, 2012 6:14 PM

MAGONSDAUGHTER

Quote:
Originally posted by canttakesky:
Quote:
Originally posted by Magonsdaughter:
I sometimes feel like the doctors in the US have no ethics whatsoever. If a drug is still at clinical trial stage, not only should they let you know ethically, you should not be required to pay for it.

The article was written by a physician in the UK. And Reboxetine was not in clinical trials. They were already approved by the UK version of the FDA.

I beg your pardon.

I trust Ben Goldacre, not merely because he is a relative by marriage, but because I find him a clear thinking,critical scientist.

He says it all:

"Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they're too complex to capture in a soundbite. This is why they've gone unfixed by politicians, at least to some extent; but it's also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it's not in anyone's financial interest to conduct any trials at all."

Really the issue is about the quality of research and who researches it and why.

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Sunday, September 23, 2012 8:50 PM

1KIKI

Goodbye, kind world (George Monbiot) - In common with all those generations which have contemplated catastrophe, we appear to be incapable of understanding what confronts us.

Hi Magonsdaughter

I wonder if there are significant differences between UK and US processes, and therefore significant differences in positive v negative results from manufacturers. I would like to have seen the data teased out rather than lumped together. Perhaps it's that way in the book, which isn't available online.

From the various reading that I've done over the years, there are OBVIOUS cases of positive manufacturer bias, but in the US on statistical review (using detailed data not contained in the original report) it is literally 50/ 50 as to whether more detailed, more inclusive review downgrades the product (which one would expect) or upgrades it (which one would not).

My belief is that this testing should be done by government, after all, why would you WANT to have a vested interest conducting the testing? On the face of it, that's a ridiculous proposition.

But there are other more difficult questions about testing that haven't been resolved that have to do with the statistical nature of biological testing, with placebo and nocebo effects, with standards against which you judge the medicine or therapy (placebo or standard treatment), and with placing a value on risk v benefit. And also where the rubber meets the road - in the practice of medicine as either a statistical intervention or an individual one.

And also, just to address the title of the thread, it's pretty obvious drugs do work, the question is on whom do they work, and when.

I'll probably order the book, but I suspect it'll be years and more data before I make my mind up about the best way to test drugs to get the most useful answers (with the exception I think it should be in the hands of government or universities paid by government).

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Sunday, September 23, 2012 9:04 PM

1KIKI

Goodbye, kind world (George Monbiot) - In common with all those generations which have contemplated catastrophe, we appear to be incapable of understanding what confronts us.

This is a similar conundrum, except it's about exercise, not medication. In this case the endpoint are measures THOUGHT to be meaningful to future heart risk (excerpts):

For Some, Exercise May Increase Heart Risk
http://well.blogs.nytimes.com/2012/05/30/can-exercise-be-bad-for-you/

By analyzing data from six rigorous exercise studies involving 1,687 people, the group found that about 10 percent actually got worse on at least one of the measures related to heart disease: blood pressure and levels of insulin, HDL cholesterol or triglycerides. About 7 percent got worse on at least two measures. And the researchers say they do not know why.

But counterbalancing the 10 percent who got worse were about the same proportion who had an exaggeratedly good response on at least one measure. Others had responses ranging from little or no change up to big changes, seen in about 10 percent, where risk factor measurements improved anywhere from 20 percent to 50 percent.

The problem with studies of exercise and health, researchers point out, is that while they often measure things like blood pressure or insulin levels, they do not follow people long enough to see if improvements translate into fewer heart attacks or longer lives. Instead, researchers infer that such changes lead to better outcomes — something that may or may not be true.

... In all the studies, a proportion of people, about 10 percent, had at least one measurement of heart disease risk that went in the wrong direction.

Then the researchers asked if there was some way of predicting who would have an adverse effect.

They found it was not related to how fit the people were at the start of the study, nor to how much their fitness improved with exercise. Age had nothing to do with it, nor did race or gender. In some studies subjects were allowed to take medications to control their blood pressure or cholesterol levels. In others they were not.

Medication use did not matter. The study subjects exercised at a range of intensities from very moderate to fairly intense. But intensity of effort was not related to the likelihood of an untoward effect. Nothing predicted who would have an adverse response.

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Monday, September 24, 2012 6:06 AM

FREMDFIRMA

Worth a note to that, in regards to rigging clinical trials...
Gardasil...

Not only was the sample size too damn small, and did not include their intended market anyways, they also front-loaded the results by using a "placebo" laced with an adjuvant known to cause adverse reactions.
What pissed me off was that in spite of this no one would friggin listen till the bodies started piling up.

Doctors are like auto mechanics for the human body, they're not infallible, and not always trustworthy either, that whole doctor-as-diety perception needs to go, and quick-like.

-Frem

ETA: I totally forgot to include WHICH drug, d'oh!
My brain ain't workin too well right now due to severe cat deprivation.

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Wednesday, September 26, 2012 7:30 PM

RIONAEIRE

Beir bua agus beannacht

Well all I know is that after my stint of getting off regular medicine for my mental health differences and trying naturopathic options, from Oct. to Aug. of this year, I was really glad to get back to taking the regular stuff that helps my mood component, because I feel sooooooooooooooo much more like me again instead of feeling like the evil hagbeast of death and doom. I had very little success in the naturopathic experiment, though we tried several things and several different avenues. I do think that everyone should give it a go if they can, in case it will work for them, since it does for some, but I'm glad I've gotten back to taking my stuff. Now if we could find something that helps with my other components I'd be doing good, but those components are a lot harder to treat for me it seems. Multi pronged mental illness sucks sometimes.

"A completely coherant River means writers don't deliver" KatTaya

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Thursday, September 27, 2012 7:21 AM

NIKI2

Gettin' old, but still a hippie at heart...

Quote:
I think the average joe six pack CAN understand this stuff.

The problem, at its heart, is that people are lazy about medications. The "doctor as god" mentality persists even to this day, despite the fact that the difference between the old "family doctor" who lived within the small community and cared about his patients and today's 15-minute-at-a-time, as-many-patients-as possible doctors is vast and no longer justifies the trust it once did (and even then...).

Patient: "I have a headache"

Doctor: "Have this prescription filled and take as directed."

Patient: "Okay".

That's how it goes for the vast majority of people. Many of us in the mental-health community have learned to ask questions, challenge p-docs' prescriptions, etc., but far too few still do--usually those of us who do have had experiences which taught us not to have so much faith. But the fact remains that, whatever the drug and however it's approved, people will take what's given to them, and probably not even read any warnings on the labels, or anything else unless they see some kind of warning on TV. Even then, how many men have taken Viagra, etc., when they have no reason to? So you have to fix that first, THEN go on to how to educate people.

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